At a US Senate hearing on September 14, FDA renewed its request for new tools to more effectively and efficiently oversee the global supply chain and better protect the public from substandard, adulterated and counterfeit drug products.
The legislation FDA is seeking would grant it the authority to: ● refuse product admission into the US from a foreign facility that has denied or repeatedly delayed agency inspections ● mandate drug product recalls ● set national track and trace standards ● require unique facility identifiers ● require more information on imported products at the border ● impose increased civil and criminal penalties on foreign and domestic drug suppliers for counterfeiting and adulteration, and ● require drug manufacturers to ensure the quality of their raw material and API supply chains and share related information with the agency.
FDA Deputy Commissioner for Global Regulatory Operations and Policy Deborah Autor stressed at the hearing that the legislative enhancements are needed to create a more level playing field between domestic and foreign manufacturers. The importance of leveling the playing field was a dominant theme voiced by the various participants at the hearing.
The agency’s effort over the last few years to secure additional authorities was spurred by the heparin crisis, which prompted two weeks of Congressional investigation in April 2008 into the agency’s ability to regulate a complex global supply chain. [Editor’s note: See the IPQ May/June 2008 Special Report for an in-depth analysis of those hearings and the case that FDA made at them for the additional authorities.]
In the wake of the heparin hearings, the house drafted an “FDA Globalization Act of 2008,” and the Senate introduced a “Drug and Device Accountability Act of 2008,” which targeted additional authorities for FDA. The House bill was reintroduced under the same name in 2009 and a similar bill followed in late 2010 entitled the “Drug Safety Enhancement Act of 2011.” In August of last year, the Senate introduced the “Drug Safety and Accountability Act of 2010” (IPQ “In the News” August 11, 2010), which again put the enhanced FDA authorities on the legislative table.
[An analysis of the dialogue at the September Senate hearing and related comments from Autor at the PDA/FDA conference on September 19 are provided for subscribers here. Non-subscribers may purchase the story for $95 by contacting Jonathan Trethowan (Jonathan@ipq.org). For subscription/license information, click here.]
See related stories:
FDA’s Foreign Office Experience Supports Their Benefit to Global Supply Chain Regulation
International Information Sharing is Impacting FDA Inspection and Enforcement Decision-Making
California’s Findings of Gaps in Heparin Recalls Highlighted at FDA Track and Trace Workshop
Increasing Cargo Theft of Pharmaceuticals May Have Brand Impact and Result in Recalls
International Joint API Inspection Pilot Program Sees Positive Results
FDA/EMA Joint Inspection Program for Finished Products Seeking Applicants
FDA Shares Concerns, Expectations Regarding Pharma Cargo Thefts
